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Multiparametric Assessment to Investigate Prognostic Factors for Disease Evolution a nd Evolutionary Patterns of Cognitive Status in RRMS (COGNIT-MS)

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Multiparametric assessment

About this trial

This is an interventional other trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring MRI, evoked potentials, cognitive function, PROMs

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

active MS, according to the Lublin criteria
disease duration < 10 years before initiating or changing a disease-modifying therapies,
relapse- and steroid-free for at least 1 month before MRI acquisition
between 18-50 years old
having given informed consent
with no significant comorbidity other than MS or substance abuse that could interfere with cognitive performances

Exclusion Criteria:

progressive forms of MS

Sites / Locations

CHU UCL Namur site GodinneRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

RRMS patients

Arm Description

RRMS patients initiating a new DMT

Outcomes

Primary Outcome Measures

Predictors of disease evolution

EDSS score worsening from baseline

evaluation of evolutionary patterns of cognitive status (impaired vs non impaired)/changes from baseline

changes from baseline in cognitive scores

baseline predictors of future cognitive impairment

abnormal cognitive performances based on cognitive scores (using BCcogSEP battery)

Secondary Outcome Measures

alteration in strategic white matter tracts at the early stages of RRMS, in patients with and without cognitive impairment

fractional anisotropy

predictive role of mEPS in predicting future disability

the Global Evoked Potential (GEP) score at study entry (baseline); EDSS score changes from baseline

Full Information

NCT ID

NCT05510817

First Posted

August 17, 2022

Last Updated

August 19, 2022

Sponsor

University Hospital of Mont-Godinne

Collaborators

Saint-Luc University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05510817

Brief Title

Multiparametric Assessment to Investigate Prognostic Factors for Disease Evolution a nd Evolutionary Patterns of Cognitive Status in RRMS

Acronym

COGNIT-MS

Official Title

Multiparametric Clinical, Radiological, Neuropsychological, and Neurophysiological Assessment to Investigate Prognostic Factors for Disease Evolution and Treatment Response in MS: a Prospective Study.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 6, 2022 (Actual)

Primary Completion Date

June 6, 2026 (Anticipated)

Study Completion Date

June 6, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital of Mont-Godinne

Collaborators

Saint-Luc University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This prospective study combining non conventional MRI techniques, neuropsychological screening tools, and a neurophysiological work-up using a sensitive and validated battery, will evaluate the predictive value of these measures and will explore the changes of the cognitive scores from baseline.

Detailed Description

Neurologists are in need for reliable and robust predictive factors enabling to predict disease evolution and treatment response. Moreover, recent studies suggested that the evolution patterns of cognitive status in MS could be mixed, contradicting the concept that cognitive impairment in MS will inevitably increase over time. The main aim of this prospective study is to investigate the predictors of disease evolution, as measured by the EDSS score, using a multiparametric assessment combining neuropsychological tests (BCcogSEP battery), MRI-derived metrics (volumetric brain parameters, tractography, diffusion tensor imaging and fiber tracking), patient-reported outcome measures, and neurophysiological tools (multimodal evoked potentials), and to explore the evolutionary patterns of cognitive status (changes from baseline). The investigators planned to include 50 patients with active RRMS and initiating a new disease-modifying treatment. Yearly assessment starting from study inclusion will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Relapsing-Remitting

Keywords

MRI, evoked potentials, cognitive function, PROMs

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RRMS patients

Arm Type

Other

Arm Description

RRMS patients initiating a new DMT

Intervention Type

Other

Intervention Name(s)

Multiparametric assessment

Intervention Description

neuropsychological assessment, PRO measures, non-conventional MRI metrics

Primary Outcome Measure Information:

Title

Predictors of disease evolution

Description

EDSS score worsening from baseline

Time Frame

3 years

Title

evaluation of evolutionary patterns of cognitive status (impaired vs non impaired)/changes from baseline

Description

changes from baseline in cognitive scores

Time Frame

3 years

Title

baseline predictors of future cognitive impairment

Description

abnormal cognitive performances based on cognitive scores (using BCcogSEP battery)

Time Frame

3 years

Secondary Outcome Measure Information:

Title

alteration in strategic white matter tracts at the early stages of RRMS, in patients with and without cognitive impairment

Description

fractional anisotropy

Time Frame

3 years

Title

predictive role of mEPS in predicting future disability

Description

the Global Evoked Potential (GEP) score at study entry (baseline); EDSS score changes from baseline

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: active MS, according to the Lublin criteria disease duration < 10 years before initiating or changing a disease-modifying therapies, relapse- and steroid-free for at least 1 month before MRI acquisition between 18-50 years old having given informed consent with no significant comorbidity other than MS or substance abuse that could interfere with cognitive performances Exclusion Criteria: progressive forms of MS

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Frédéric London, MD

Phone

+3282413345

frederic.london@chuuclnamur.uclouvain.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frédéric London, MD

Organizational Affiliation

University Hospital Mont-Godinne

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU UCL Namur site Godinne

City

Yvoir

State/Province

Namur

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frédéric London, MD

Phone

+3281423345

frederic.london@chuuclnamur.uclouvain.be

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Multiparametric Assessment to Investigate Prognostic Factors for Disease Evolution a nd Evolutionary Patterns of Cognitive Status in RRMS

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